# FDA recall Z-1947-2019

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2019-05-28.

## Product

DVR Crosslock ePAK Depth Gauge, Model Number 212000003    Product Usage:  These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

## Reason for recall

There is a potential for weak seals of the sterile packaging.

## Distribution

Worldwide Distribution - US Nationwide:  AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH OK, OR, PA, SC, TN, TX, UT, WA, WI, WV, and Puerto Rico.    Products were distributed to the following foreign countries:  Australia, Canada, Chile, Japan, Netherlands.

## Key facts

- **Recall number:** Z-1947-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2019-07-10
- **Termination date:** 2021-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2019

## Citation

> AI Analytics. FDA recall Z-1947-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1947-2019. Source: US FDA. Licensed CC0.

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